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Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

NCT01709968 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2017-07-21

No results posted yet for this study

Summary

Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to investigate the effect of treatment with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide \& Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the number and severity of NLC; an improvement in the quality of life and quality of sleep may ensue.

Conditions

  • Nocturnal Leg Cramps
  • Quality of Life

Interventions

DRUG

MAGNOX 520®

un-organic granular magnesium complex, composed of Magnesium Oxide \& Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks

DRUG

placebo

Similarly looking placebo. Oral administration once daily for 4 weeks

Sponsors & Collaborators

  • Uzi Milman

    lead OTHER

Principal Investigators

  • Noga Maor Rougin, MD · Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL

  • Uzi Milman, MD · Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-10-31
Completion
2014-04-30

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709968 on ClinicalTrials.gov